Suture package

ABSTRACT

A surgical suture package, primarily for double armed multistrand sutures, retains each individual suture in a predetermined sinusoidal configuration within adjacent but separate compartments. Notches along one edge of the package secure the armed ends of each suture which are held in place within the package when the compartments are folded together. As the package is unfolded, the armed ends are exposed sequentially, facilitating removal by the surgeon of each suture from its compartment one at a time without tangling and kinking.

United States Patent 1 [111 3,759,376 Lisowski Sept. 18, 1973 SUTURE PACKAGE 3,357,550 12/1967 Holmes et al ..206/63.3

[75] Inventor: Borys Lisowski, Union, NJ.

[73] Assignee: Ethicon, lnc., Somerville, NJ.

[22] Filed: Feb. 14, 1972 211 App]. No.: 225,814

[52] US. Cl 206/63.3, 53/21 FW, 206/64 [51] Int. Cl A611 17/02 [58] Field of Search 206/63.3,'64

[56] References Cited UNITED STATES PATENTS 3,206,018 9/1965 Lewis et al 206/633 2,692,676 10/1954 Grover 206/633 975,205 11/1910 Booth 206/64 3,062,372 11/1962 Egler et al. 206/633 Primary Examiner-Leonard Summer Att0mey-Robert W. Kell et al.

[57] ABSTRACT A surgical suture package, primarily for double armed multi-strand sutures, retains each individual suture in a predetermined sinusoidal configuration within adjacent but separate compartments. Notches along one edge of the package secure the armed ends of each suture which are held in place within the package when the compartments are folded together. As the package is unfolded, the armed ends are exposed sequentially, facilitating removal by the surgeon of each suture from its compartment one at a time without tangling and kinking. I

4 Claims, 12 Drawing Figures PATENIEDSEH elm SHEEI 1 BF 3 PAIENIEU sm ems SHEU 3 0F 3 double armed, braided silk sutures and the like packaged in this manner.

When the term suture or sutures is used in this application, it shall mean elongated strands suitable for suturing, ligating, or surgical procedures and shall include those strands commonly called sutures and ligatures.

When the term double armed sutures is used in this application, it shall mean a suture that has affixed to each end thereof a surgical. needle. 2

. When the term muIti-strand package is used in this application, it shall mean a package containing a plurality of suture strands, i.e., four to six or more.

I-leretofore, double armed sutures have been packaged in various ways intended to minimize the formation of kinks or sharp bends in the suture strand due to packaging. Forinstance, the suture has been wound upon circular reels and various other attempts have been made to coil the suture smoothly and in such a way that no kinks will be formed. Necessarily, when the suture has been coiled in this manner, it has been re tained in the package in coiled form for an extended period of time prior to use. As a result,the suture strands adopt a set configuration based upon the form in whichit was coiled, even when they are removed from the packageThus, when asuture which has been coiled iri circular form on a reel is removed from the reel, it will tend to return or snap back into a circular configuration. When the suture is attached to a needle, as it normally is for suturing purposes, the surgeon must prevent the suture strand from coiling up against the needle and interfering with'the surgical procedure. This is a difficult problem because it is almost impossible to prevent sutures from assuming a set during packaging.

The problem referred to above is accentuated when the suture has a needle attached to both ends as the suture hasa tendency to coil up against the needles at either end thereof making it difficult for the surgeon to handle. The present package permits the surgeon to grasp one needle in a needle holder and remove the su ture from thep'ackage without entangling the suture with theneedle that is attached-to the other end.

Because a large number of doublearmed sutures are frequently used in asingle surgical procedure, it is de sirable to package a number of identical sutures, i.e., four to six or more-in a single packageln such multi strand packages, it is important to immobilize the needles attachedto each suture so that they remain sepa other rated from and do not become entangledwith double 'armed sutures within the package.

imposed one upon the other in successive layers with the convolutions disposed in sequence from one end of the suture to the other. Each of the figure-eight convolutions comprise a centrally located suture crossing, and opposed loops on each side of the crossing with the loops also integralwith the suture portions forming the crossings- As a result, the coils within each compartment are maintained'in sequence and in layers in the suture crossings since these crossings prevent adjacent convolutions from telescoping or entangling with one another. When the suture is coiled in this manner and removed from the package by drawing up one of its ends, it assumes a non-entangling sinusoidal configuration of successive positive and negative lobes. When the suture is held by theneedle at one end thereof, it remains extended inthis form and has no tendency to coil up again adjacent the needle at either end.

In the preferred form of our invention and most particularly, when the suture is a stifi monofilament, the suturing needle that is attached to the ends of the suture is curved and each needle is retained in the package in such a way that when the suture is removed therefrom as described above, the point of the needle is directed away from the next adjacent suture lobe thereby assuring that the suture will trail behind the needle point during surgery. To accomplish this,-both curved needles and the suture end attached thereto are retained in the package in such a way-that the curve of the needle and the suture end attached thereto generally follows the curved configuration of the suture coil. The suture ends are arranged so that they generally continue to follow the shape of the figure-eight and the needles attached thereto are positioned in such a way that they appear to be a continuation of the coil configuration.

In the package of this invention, each individual suture is held in the'desired coilform within adjacent compartments foldably connected with one another In accordance with the present invention, a folded package for multi-strand double armedsutures is provided which will hold two to six or more sutures in a predetermined sinusoidal configuration'within adjacent but separate compartments. Notches along one edge of the package secure the armed endsof each suture so that the attached needles are locked in position as the compartments are folded together. The package of the present invention permits the surgeon or his assistant to remove each suture one at a time and as needed with out entanglement. J

In accordance with the present invention, the suture is wound in the form of a coil similarto that described in U.S. Pat. No. 3,444,994. The suture coil has a multiplicity of figure-eightconvolutions which are superand adapted to be folded together .and superimposedso that the figure-eight suture coils in each compartment are in registry and the armed ends of the suture and attached needles extend from adjacent ends of each compartnient. Preferably, there is a notch in the open end of each compartment along one edge of the package to hold the armed side of the suture in position until the compartments are folded together. v

The double armed suture may be wound as it isbeing positioned within each compartment of the package by employinga jig which cooperates with or penetrates a portion of the package as will be described more fully hereinafter. The package is adapted to be closed easily by foldingand held together with a retaining sleeve which secures the coil convolutions and needles'in the desired relationship within the package. The package with the sutures in position therein is then hermeticallysealed in an outer container and sterilized with gamma radiation. A

Other and further advantages: of this invention will appear to one skilled in the art from the followingdescription and claims taken together with the drawings wherein: a

FIG. 1 is a perspective view of top and bottom sheets that form the suture package of the present invention.

FIG. 2 is a perspective view of a double armed suture.

FIG. 3 is a perspective view of a winding jig inserted through slots provided for this purpose in the bottom sheet of the suture package.

FIG. 4 is a perspective view of the winding jig of FIG. 3 showing the armed sutures and top sheet in place for heat sealing.

FIG. 5 is an enlarged schematic view, partially in section and partially in elevation, of the winding jig and heat seal unit as viewed in the direction of Arrow 5 in FIG. 4.

FIG. 6 is an enlarged schematic view, partially in section and partially in elevation, of the winding jig illustrated in FIG. 5 showing the heat seal unit in its sealing position.

FIG. 7 is an enlarged schematic view partially in section and partially in elevation of the winding jig and heat seal unit illustrated in FIG. 5 as viewed in the direction of Arrow 7 in FIG. 4.

FIG. 8 is a perspective view of a four-compartment double armed multi-strand suture package of the present invention.

FIG. 9 is a perspective view of the suture package illustrated in FIG. 8, partially folded. 1

FIG. 10 is a perspective view of an over-wrap and the folded package of FIG. 9 with a retaining sleeve in place.

FIG. 11 is a perspective view of the package after the over-wrap is heat sealed.

FIG. 12 is a perspective view of the package of the present invention and shows a surgeon removing a double armed suture from its compartment.

Referring to the drawings, FIG. 1 shows a bottom sheet 20, preferably 27 lb. per ream bleached Kraft paper, that has been coated on one side with a film 21 of low porosity polyethylene heat sealing composition. The edge 19 of the bottom sheet is cut with keyhole notches 31 which serve to retain in alignment the armed ends of the suture. A top sheet 23 of bleached Kraft paper, preferably, about 5 mils. in thickness, is heat sealed along the fold lines 24 and edges 25 to the bottom sheet to form the package of the present invention.

FIG. 2 shows a double armed suture 27, having a needle 28 attached to each end thereof. The suture is wound on a fixture in the form of a coil comprising a multiplicity of figure-eight convolutions each of which is in the form of a centrally located suture crossing 29 with opposed loops 30 integral with the suture portions forming the crossings 29. As most clearly shown in FIG. 3, this results in a figure-eight coil wherein the convolutions are super-imposed one upon the other in successive layers at the suture crossings with the convolutions disposed in sequence from one end of the suture to the other.

The method of winding the sutures prior to formation of the package and the operation of a jig which facilitates the hand winding of the armed sutures may be best understood with reference to FIGS. 3, 4, 5, 6, and 7. In FIGS. 3-7 of the drawings, there is shown the formation of a suture package according to one embodiment of this invention which comprised four compartments in each of which a double armed suture is coiled. The needles 28 that extend from one end of each compartment are retained in notches 31 located along the open edge of the lower sheet 20. As best shown in FIG. 3, the suture package is assembled by first placing the bottom sheet 20 on the jig 32 with the polyethylene film 21 upward so that the pins 33 and 34 of the jig project through the holes 33' and 34 in the sheet. The hole 34 is elongated to permit lateral movement of bar 35 which supports the pin 34 as may be desired to accommodate winding sutures of different length. All of these pins and the supporting bar 35 are then held in the desired position by tightening the thumb screws 36 and 36'.

After the bottom sheet is placed in position, the suture 27 is looped around the pin 34 and tension is applied to the needle 28 and 28' which are held together. Then the suture 27 is wound in the form of a figure eight coil around the pins 33 and 34. The double armed ends of the suture are drawn through the notch 31 and laid in the channel 37 beneath the sheet 20. The top sheet 23 is then placed over the bottom sheet 20 as shown in FIG. 4 and the heat sealing unit is moved downwardly to the position indicated in FIG. 6.

From FIGS. 5 and 6 it will be observed that as the heat seal unit 38 is moved downward projections 39 and 39 at each end thereof contact the plate 40 which is spring-biased by springs 41, 42, 43 (not shown), and 44 to hold the pins 33 and 34 in their uppermost position. The supporting plate 40 and pins 33 and 34 are thereby forced down compressing springs 41, 42, 43, and 44. Simultaneously, the heating elements 45 of the heat seal unit contact the top sheet 23 exerting heat and pressure and thereby forming a longitudinal seal between the coiled sutures and adjacent compartments along Lines 24.

The sealed package with the double armed sutures in place is then removed from the jig and positioned with the notched edge 19 along the top so that the needles are hanging perpendicular as shown in FIG. 8. The notches help guide the armed ends of the sutures in folding the package. FIG. 8 clearly shows the type of suture and needle configuration. imparted by packaging in this manner.

The package is folded inwardly in the direction of the arrowsin FIG. 9 along the heat seal lines 24 and a paper retaining sleeve 48 is slipped over the suture package as illustrated in FIG. 10 to prevent opening of the'folder. The retaining sleeve may be formed from any suitable relatively stiff sheet material, such as conventional paper board or the like.

The folded double armed multi-strand suture-package is then overwrapped by placing it within an outer envelope of coated paper 50 that is heat sealed to provide a hermetically sealed over-wrap envelope that is illustrated in FIG. 11. The over-wrap envelope has a tear line 52 at one end for opening the envelope when it is desired to obtain access to the suture. This packagemay be sterilized by gamma rays and is then ready for shipping and storage. 7

In use, the surgeon or his assistant may remove the I outer wrapper by grasping it on either side of the notch 52 and tearing to eject the sterile primary package and retaining sleeve 48. The retaining sleeve is removed from the folded package which is then opened by the surgeon and the double armed sutures may be removed sequentially one at a time without kinking or entanglement as best illustrated in FIG. 12.

It shall be noted that the curved needle 28 is disposed in such a way that it appears to continue the sinusoidal shape of the suture. The suture now tends to retainfthis sinusoidal shape and has no tendency to snap back into its original coiled form. As a result of this and the fact that the point of the needle is directed away from the next adjacent suture lobe, it is assured that the suture will trail behind the needle point during surgery and will not interfere with the surgical procedure in any way. The sinusoidal lobes 37 of the suture may initially be less pronounced than shown schematically in FIG. 8, or may become somewhat less pronounced after the suture is removed from its retainer.

What is claimed is:

1. A multi-strand suture package comprising a foldable card of relatively stifl material rectangular in shape having a bottom edge, a top edge, and two side edges; and overlying sheet sealed to the bottom edge of said card and along fold lines parallel to said side edges to form a plurality of adjacent compartments that are open at the top edge of said card; each compartment containing a double-armed suture wound in the form of a coil comprising a multiplicity of figure-eight convolutions each of which comprise a centrally located suture crossing and opposed loops on each side of said crossing and integral with the suture portions forming the crossing, the suture crossings of successive figure-eight convolutions being superimposed one upon the other to dispose the convolutions in successive layers; a needle affixed to each end of each suture and extending from the open end of each compartment toward the bottom-edge of said card, said card being folded inwardly toward the overlying sheet along the fold lines to bring adjacent compartments together with the coiled sutures in registry and the needles in position between adjacent compartments; and means for retaining the folded card in its folded position to form a suture package whereby as the package is unfolded, said armed ends are exposed sequentially facilitating removal by the surgeon of each suture from its compartment one at a time without tangling or kinking.

2. The suture package of claim 1, wherein the means for retaining said card in its folded position is a paper retaining sleeve.

3. A suture package according to claim 1, characterized by a key-hole notch positioned near said open edge of each compartment that functions to retain said needles in a fixed position when adjacent compartments are folded together.

4. A sterile suture package according to claim 1, en-

closed in a hermetically sealed envelope. 

1. A multi-strand suture package comprising a foldable card of relatively stiff material rectangular in shape having a bottom edge, a top edge, and two side edges; and overlying sheet sealed to the bottom edge of said card and along fold lines parallel to said side edges to form a plurality of adjacent compartments that are open at the top edge of said card; each compartment containing a double-armed suture wound in the form of a coil comprising a multiplicity of figure-eight convolutions each of which comprise a centrally located suture crossing and opposed loops on each side of said crossing and integral with the suture portions forming the crossing, the suture crossings of successive figure-eight convolutions being superimposed one upon the other to dispose the convolutions in successive layers; a needle affixed to each end of each suture and extending from the open end of each compartment toward the bottom edge Of said card, said card being folded inwardly toward the overlying sheet along the fold lines to bring adjacent compartments together with the coiled sutures in registry and the needles in position between adjacent compartments; and means for retaining the folded card in its folded position to form a suture package whereby as the package is unfolded, said armed ends are exposed sequentially facilitating removal by the surgeon of each suture from its compartment one at a time without tangling or kinking.
 2. The suture package of claim 1, wherein the means for retaining said card in its folded position is a paper retaining sleeve.
 3. A suture package according to claim 1, characterized by a ''''key-hole'''' notch positioned near said open edge of each compartment that functions to retain said needles in a fixed position when adjacent compartments are folded together.
 4. A sterile suture package according to claim 1, enclosed in a hermetically sealed envelope. 